Cleared Traditional

K974238 - DENTAL TRAY

K974238 is an FDA 510(k) clearance for DENTAL TRAY, manufactured by Trinity Laboratories, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K974238 · Trinity Laboratories, Inc. · Dental device
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Feb 1998
Decision
84d
Days
Class 1
Risk

K974238 is an FDA 510(k) clearance for the DENTAL TRAY, STERILE, DISPOSABLE. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on February 4, 1998 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Trinity Laboratories, Inc. devices

FDA 510(k) Submission Details - K974238

510(k) Number K974238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1997
Decision Date February 04, 1998
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIA Unit, Operative Dental

All 86
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K974238.
SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES
K983242 · Sirona Dental Systems GmbH · Dec 1998
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998
WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM
K981937 · Welch Allyn, Inc. · Aug 1998
VIOLA II DENTAL CAMERA SYSTEM
K973035 · Innovative Medical Systems, Inc. · Sep 1997
PEFECT SHOT
K972019 · International Imaging Electronics · Jul 1997
PLANMECA INTRACAM
K972033 · Planmeca Oy · Jun 1997